DeviceClearance

Product code QKV— Ophthalmic

iTEAR Neurostimulator

Classification name
Electromechanical Tear Stimulator
Device class
Class 2
Regulation
21 CFR 886.5305
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

FDA classification definition

“This device type is a non-implantable device intended to increase tear production via mechanical stimulation.”

— U.S. Food and Drug Administration, device classification record for product code QKV under 21 CFR 886.5305, via openFDA

Market context for product code QKV

FDA has cleared 2 devices under product code QKV between 2020 and 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QKV

Recent clearances under product code QKV

Data sourced from openFDA. This site is unofficial and independent of the FDA.